FDA Approves Dosing Reduction of Tecvayli in Relapsed, Refractory Myeloma

The Food and Drug Administration (FDA) has approved a reduced dosing frequency of Tecvayli (teclistamab-cqyv) of 1.5 mg/kg every two weeks for patients with relapsed or refractory multiple myeloma who have achieved and maintained a complete response (CR; when the patient’s cancer completely disappears) or better for at least six months, according to a news release from drug manufacturer, Johnson and Johnson.

Tecvayli — the first BCMA-directed CD3 T-cell engager approved for this patient population, which binds to certain types of T cells, which find and attack the cancer — was originally approved by the FDA in October of 2022 for patients with relapsed or refractory multiple myeloma who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody. The approval was at a recommended dose of 0.06 mg/kg administered via subcutaneous injection on day 1; 0.3 mg/kg on day 4; and 1.5 mg/kg on day 7 followed by 1.5 mg/kg once weekly until disease progression or unacceptable toxicity.

"Tecvayli is the only BCMA-targeted immune-based therapy with weight-based dosing. Today's approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules," said Dr. Rachel Kobos, vice president, oncology research and development, Johnson and Johnson Innovative Medicine, in a news release issued by the manufacturer. "As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, Tecvayli is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma."

The reduced dosing approval was based on findings from the phase 1/2 MajesTEC-1 study. Findings presented at the 2023 American Society of Hematology Annual Meeting, showed that among 104 real-world patients — meaning those who were treated in clinics and not in a trial setting — showed the overall response rate (ORR; patients whose disease shrunk or disappeared from treatment) was 66%, versus 63% among patients in the MajesTEC-1 trial, with CR rates of 29% and 39.4%, respectively.

The new indication, the manufacturer noted in its news release, was approved under accelerated approval based on response rate, and “continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”

Johnson and Johnson reported that the most common side effects to Tecvayli, occurring in at least 20% of patients, included pyrexia (fever), cytokine release syndrome (a rapid release of proteins called cytokines in the blood which can lead to symptoms including nausea, fever, rash, headache, low blood pressure, rapid heartbeat and trouble breathing), musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia and diarrhea, while the most common grade 3 to 4 laboratory abnormalities in at least 20% of patients were decreased white blood cells including lymphocytes and neutrophils, decreased hemoglobin (a protein found in red blood cells) and decreased platelets.

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